Cleared Traditional

BIOPSY FORCEPS

K895098 · Annex Medical, Inc. · Cardiovascular
Oct 1989
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K895098 is an FDA 510(k) clearance for the BIOPSY FORCEPS, a Device, Biopsy, Endomyocardial (Class II — Special Controls, product code DWZ), submitted by Annex Medical, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on October 30, 1989, 76 days after receiving the submission on August 15, 1989. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4075.

Submission Details

510(k) Number K895098 FDA.gov
FDA Decision Cleared SESE
Date Received August 15, 1989
Decision Date October 30, 1989
Days to Decision 76 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DWZ — Device, Biopsy, Endomyocardial
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4075